Recall Z-1992-2019 ยท DBI Complement C4, Antigen, Antiserum, Control
Abbott Laboratories, Inc
C4 is an in vitro diagnostic assay for the quantitative determination of C4 in human serum or plasma. Antigen in the sample bonds to the specific antibody in the reagent, forming an immune complex. The immune complex causes an increase in light scattering, measured by reading turbidity at 604 nm, which correlates with the concentration of C4 in the sample.
| Date | May 16, 2018 |
| Status | Terminated |
| Reason | An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the various products. |
| Root cause | Under Investigation by firm |
| Action | The recalling firm issued letters dated 5/16/2019 via FedEx priority overnight express on 5/16/2019 to the U.S. customers. For OUS, each country organization needs to establish their own method of notification, which normally consists of mailings or customer visits. |
| Quantity | 8,037 kits |
| Distribution | Distribution was nationwide, including Puerto Rico. There was government/military distribution. Foreign distribution was made to Canada, Albania, Algeria, Andorra, Argentina, Armenia, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovi, Botswana, Brazil, Bru |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K983356 | C4 Abbott Laboratories, Nov 4, 1998 |